Henriksen 2003a.
Methods | Randomised clinical trial, Denmark | |
Participants | 58 hospitalised adults admitted for bowel resection, at nutritional risk due to major surgery Male:Female = 21:37 Mean age = 63.7 years Exclusion criteria: inflammatory bowel disease, disseminated malignant disease, previous treatment for intra‐abdominal cancer, serious cardiovascular disease (New York Heart Association angina class III and IV) diabetes mellitus, disabling mental disease, dementia or a history of alcoholic, medicine or drug abuse |
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Interventions | The night before surgery: Experimental group 1: 12.5 g/100 ml carbohydrate (maltodextrin) drink (n = 16) Experimental group 2: 2.5 g/100 ml carbohydrate (maltodextrin) and 3.5 g/100 ml of hydrolyzed soy protein (n = 16) Control group: No treatment (n = 8) Co‐interventions: Pure water until 3 hrs before induction of anaesthesia + basic postoperative regimen |
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Outcomes | Voluntary grip and quadriceps strength, body composition, pulmonary function, VAS‐score of 8 parameters of well‐being, muscle biopsies and insulin, glucagon, IGF‐1 and free fatty acids | |
Study dates | Not stated | |
Notes | We contacted the authors on 19th August 2015 by email: gaarden@dadlnet.dk . We received a reply. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | The trial used sealed envelopes for allocation but it was unclear if they were opaque. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Nutritional status was described as blinded, but it was unclear how the rest of the outcomes were assessed. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The number of dropouts exceeds 5%. The dropouts were described, but it was unclear from which group they came. |
Selective reporting (reporting bias) | Unclear risk | No protocol could be obtained, and the trial did not report all‐cause mortality or serious adverse events. |
For‐profit bias | Unclear risk | It was unclear how the trial was funded. |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |